ID

24536

Descripción

Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00559611

Link

https://clinicaltrials.gov/show/NCT00559611

Palabras clave

Versiones (2)
  1. 5/8/17 5/8/17 -
  2. 5/8/17 5/8/17 -
Subido en

5 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00559611

Inglés

Eligibility Lung Cancer NCT00559611

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient must be >/= 18 years old.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patient must have ecog/zubrod status 0, 1, or 2.
Descripción

ECOG performance status | Zubrod Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C3714786
3. patient must have clinically resectable, nsclc (squamous cell, adenocarcinoma, sarcomatoid, neuroendocrine or large cell) and be clinical stage iiia, according to the 1998 staging system of the american joint commission on cancer for lung cancer.
Descripción

Non-Small Cell Lung Carcinoma Resectable AJCC tumor staging | Squamous cell carcinoma of lung | Adenocarcinoma of lung | Lung Sarcomatoid Carcinoma | neuroendocrine carcinoma of lung | Large cell carcinoma of lung

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C0441915
UMLS CUI [2]
C0149782
UMLS CUI [3]
C0152013
UMLS CUI [4]
C1708781
UMLS CUI [5]
C2200127
UMLS CUI [6]
C0345958
4. patient must have proven or suspected nsclc prior to registration. patients who obtain subsequent pathologic confirmation of nsclc at the time of ebus or subsequent surgery will remain enrolled on the study. patients subsequently found to have an etiology other than nsclc will be excluded from further analysis.
Descripción

Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Carcinoma Suspected | Endobronchial ultrasound | Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C3160856
UMLS CUI [4]
C0543467
5. patient must be anticipated to have definitive therapy for primary nsclc. this may include surgery, chemotherapy, radiation therapy or a combination the above.
Descripción

Definitive Treatment Non-Small Cell Lung Carcinoma Primary | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986592
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0009429
6. patient must be medically fit for definitive therapy.
Descripción

Patient Fit Definitive Treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0424576
UMLS CUI [1,3]
C2986592
7. patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Descripción

Informed Consent | Informed Consent Patient Representative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has received prior chemotherapy or radiotherapy for this cancer.
Descripción

Prior Chemotherapy Non-Small Cell Lung Carcinoma | Prior radiation therapy Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0007131
2. patient is considered a poor risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Descripción

Risk Poor Due to Systemic disease | Cardiovascular Diseases | Kidney Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0442893
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0022658
3. patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: latex allergy; bleeding diathesis; previous mediastinoscopy; previous mediastinal nodal resection; previous tracheostomy.
Descripción

Medical contraindication Endobronchial ultrasound | Medical contraindication Mediastinoscopy | Latex allergy | Bleeding tendency | Mediastinoscopy Previous | Excision Mediastinal nodes | Tracheostomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3160856
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025065
UMLS CUI [3]
C0577628
UMLS CUI [4]
C1458140
UMLS CUI [5,1]
C0025065
UMLS CUI [5,2]
C0205156
UMLS CUI [6,1]
C0728940
UMLS CUI [6,2]
C0588055
UMLS CUI [7]
C0040590
4. patients malignancy not consistent with nsclc
Descripción

Malignant Neoplasms | Non-Small Cell Lung Carcinoma Consistent with Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0332197
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Similar models

Eligibility Lung Cancer NCT00559611

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient must be >/= 18 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Zubrod Performance Status
Item
2. patient must have ecog/zubrod status 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
C3714786 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma Resectable AJCC tumor staging | Squamous cell carcinoma of lung | Adenocarcinoma of lung | Lung Sarcomatoid Carcinoma | neuroendocrine carcinoma of lung | Large cell carcinoma of lung
Item
3. patient must have clinically resectable, nsclc (squamous cell, adenocarcinoma, sarcomatoid, neuroendocrine or large cell) and be clinical stage iiia, according to the 1998 staging system of the american joint commission on cancer for lung cancer.
boolean
C0007131 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0441915 (UMLS CUI [1,3])
C0149782 (UMLS CUI [2])
C0152013 (UMLS CUI [3])
C1708781 (UMLS CUI [4])
C2200127 (UMLS CUI [5])
C0345958 (UMLS CUI [6])
Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Carcinoma Suspected | Endobronchial ultrasound | Operative Surgical Procedures
Item
4. patient must have proven or suspected nsclc prior to registration. patients who obtain subsequent pathologic confirmation of nsclc at the time of ebus or subsequent surgery will remain enrolled on the study. patients subsequently found to have an etiology other than nsclc will be excluded from further analysis.
boolean
C0007131 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C3160856 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Definitive Treatment Non-Small Cell Lung Carcinoma Primary | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Combined Modality Therapy
Item
5. patient must be anticipated to have definitive therapy for primary nsclc. this may include surgery, chemotherapy, radiation therapy or a combination the above.
boolean
C2986592 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
Patient Fit Definitive Treatment
Item
6. patient must be medically fit for definitive therapy.
boolean
C0030705 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C2986592 (UMLS CUI [1,3])
Informed Consent | Informed Consent Patient Representative
Item
7. patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma | Prior radiation therapy Non-Small Cell Lung Carcinoma
Item
1. patient has received prior chemotherapy or radiotherapy for this cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Risk Poor Due to Systemic disease | Cardiovascular Diseases | Kidney Diseases
Item
2. patient is considered a poor risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
boolean
C0035647 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0442893 (UMLS CUI [1,4])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
Medical contraindication Endobronchial ultrasound | Medical contraindication Mediastinoscopy | Latex allergy | Bleeding tendency | Mediastinoscopy Previous | Excision Mediastinal nodes | Tracheostomy
Item
3. patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: latex allergy; bleeding diathesis; previous mediastinoscopy; previous mediastinal nodal resection; previous tracheostomy.
boolean
C1301624 (UMLS CUI [1,1])
C3160856 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025065 (UMLS CUI [2,2])
C0577628 (UMLS CUI [3])
C1458140 (UMLS CUI [4])
C0025065 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C0728940 (UMLS CUI [6,1])
C0588055 (UMLS CUI [6,2])
C0040590 (UMLS CUI [7])
Malignant Neoplasms | Non-Small Cell Lung Carcinoma Consistent with Absent
Item
4. patients malignancy not consistent with nsclc
boolean
C0006826 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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